Safety and Efficacy of K-134 for the Treatment of Intermittent Claudication

Kowa Research Institute, Inc.387 enrolled

Overview

The purpose of this study is to evaluate the safety and efficacy of K-134 for the treatment of intermittent claudication.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

387

Conditions

Intermittent Claudication

Interventions

K-134DRUG

K-134 is given as low dose mid dose and high dose tablets for 26 Weeks.

Cilostazol 100 mg BIDDRUG

Cilostazol 100mg BID for 26 weeks.

PlaceboDRUG

Placebo BID for 26 weeks.

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: \- Stable claudication symptoms Exclusion Criteria: * Lower extremity amputation * Signs or symptoms of critical leg ischemia (CLI) * Uncontrolled hypertension * Tachycardia * Poorly controlled diabetes * Hypercholesterolemia

Locations (42)

Outcomes

Primary Outcomes

Improvement in peak walking time at 26 weeks

Time frame: 26 Weeks

Secondary Outcomes

Improvement in claudication onset time at 26 weeks

Time frame: 26 Weeks

Data from ClinicalTrials.gov

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Unnamed facility

Tucson, Arizona, United States

Unnamed facility

Little Rock, Arkansas, United States

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Beverly Hills, California, United States

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Los Angeles, California, United States

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Sacramento, California, United States

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Santa Rosa, California, United States

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Vista, California, United States

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Aurora, Colorado, United States

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Clearwater, Florida, United States

Unnamed facility

Gulf Breeze, Florida, United States

...and 32 more locations